The purpose of this study is to confirm the efficacy and safety of total flavonoids of
propolis dropping pill to treat angina pectoris, evaluated by total exercise time of
treadmill exercise test.
Drug: Total Flavonoids of Propolis dropping pill
Drug: total Flavonoids of Propolis dropping pill
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Locations near you
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Full eligibility criteria for NCT01453582
Ages eligible for Study
35 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
Class I, Class II and Class III stable angina pectoris, angina attack more than 3 times one week;
Qi deficiency and blood stasis syndrome of Traditional Chinese Medicine;
In resting electrocardiogram, ST-segment deviation≥0.05mv and/or T-wave inversion≥0.2mv in the leads R-wave is predominant during non-attack period, or ST-segment deviation≥0.1mv and/or T-wave inversion≥0.2mv in the leads R-wave is predominant during angina attack;
Total exercise time of treadmill exercise test≥3 minutes.The discontinuance standard should be reached. And the difference of total exercise time between before and after run in period should ≤15%;
Other confirmed diagnostic evidence of coronary heart disease, such as definite history of old myocardial infarction, or incomplete revascularization one year after coronary intervention therapy(residual luminal stenosis≥50%), or coronary angiography evidence(at least single vessel disease and luminal stenosis≥50%), or nuclein examination evidence, or computer tomography angiography evidence;
Not well controlled hypertension(systolic pressure≥160mmHg，diastolic pressure≥100mmHg), serious cardiopulmonary insufficiency, serious arrhythmia(rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc);
Serious diseases of heart, lung, liver, kidney and blood;
Allergic constitution or allergic to the components of total Flavonoids of Propolis dropping pill;
Women during pregnancy or lactation;
Received any major operation within 4 weeks;
Have been in other clinical trials within 30 days;
Using but can not withdraw anti-angina medicine as long acting nitrates;
Not well controlled hyperglycemia;
Not fit for this trial judged by investigator.
All locations for NCT01453582
Guangdong Second Provincial Traditional Chinese Medicine Hospital
Guangzhou, Guangdong, China, 510095
Ruikang Hospital of Guangxi Traditional Chinese Medical University
Nanning, Guangxi, China, 530011
Hubei Hospital of Traditional Chinese Medicine
Wuhan, Hubei, China, 430060
The Affiliated Hospital to Changchun University of Chinese Medicine
Changchun, Jilin, China, 130021
Sencond Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China, 110086
Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China, 110101
Neimenggu Hospital of Traditional Chinese and Mongolian Medicine
Huhehaote, Neimenggu, China, 010020
Shanghai Hospital of Traditional Chinese Medicine
Shanghai, Shanghai, China, 200071
Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai, China, 201203
Shanxi Hospital of Traditional Chinese Medicine
Taiyuan, Shanxi, China, 030012
Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin, China, 300150
First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin, China, 300193
Xinjiang Hospital of Traditional Chinese Medicine
Wulumuqi, Xinjiang, China, 830000
View full eligibility
Tris trial is registered with FDA with number: NCT01453582. The sponsor of the trial is Shanghai Greenvalley Pharmaceutical Co., Ltd. and it is looking for 478 volunteers for the current phase.
Official trial title: Phase III Study of Total Flavonoids of Propolis Dropping Pill in Angina Pectoris: A Randomized, Double-Blind, Placebo-Controlled Multi-Centered Clinical Trial on Efficacy and Safety.
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